BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 22364342 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04882
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    March 31, 2020
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 6/30/2025. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA: 014204. D4: BATCH#: UNK. B3: UNKNOWN; CAPTURED AS AWARENESS DATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE USE OF CURVED STAPLER IN LAPAROSCOPIC LOWER RESECTION OF THE RECTUM (LRR). AUTHORS: GRAZIELLA MARINO, LUIGI MASONI, ANTONIO BRESCIA, MARCELLO GASPARRINI, VALERIA CATRACCHIA, ANDREA MILILLO, FRANCESCO FAVI, FRANCESCO SAVERIO MARI CITATION: EUR SURG RES. 2008; 41: 59¿196. TODAY IN MANY SURGICAL DIVISIONS, THE RESECTION OF THE RECTUM IS PERFORMED LAPAROSCOPICALLY. IN THIS PROCEDURE, THE MOST DIFFICULT PART IS REPRESENTED BY SECTIONING OF THE LOWER RECTUM ESPECIALLY IN PRESENCE OF LARGE TUMORS, NARROW MALE PELVIS, AND IT OFTEN REQUIRES CONVERSION BY A PFANNESTIEL INCISION AND MANUAL COMPLETION OF THE DISSECTION. THE AUTHORS HAVE EXPERIMENTED AN ORIGINAL TECHNIQUE. THE AUTHORS ROUTINELY PERFORMED LRR BY A 3 TO 4 TROCAR TECHNIQUE AND USE FOR LOWER RECTUM SECTION THE CONTOUR STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKS (N-2). THIS RESULT IS VERY PROMISING AND WE HOPE THAT A MODIFIED DESIGN WITH AN CIRCULAR SHAFT CAN SEMPLIFICATE THIS TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291345 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention